Adult Cough and Chest Congestion — Class III drug recall D-0033-2025
Ongoing recall by Denison Pharmaceuticals, LLC, reported 2024-11-13. Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside
| Recall number | D-0033-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Denison Pharmaceuticals, LLC, Lincoln, RI, United States |
| Recall initiated | 2024-09-25 |
| Classified | 2024-11-01 |
| Reported by FDA | 2024-11-13 |
| Quantity | 72,648 bottles |
| UPC / GTIN / UDI-DI | 00850015736155 |
| NDC | 69676-0077-09, 69676-0079, 69676-0079-03, 69676-0094-09 |
| Lot numbers | 0104V, 0106V |
| Expiration dates | 2024-09, 2025-07 |
Product
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
Reason for recall
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0033-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.